Status:
COMPLETED
Assessment and Augmentation of Lip Appearance in Specific Study Populations
Lead Sponsor:
Dieter Manstein, MD
Conditions:
Lip Aging
Lip Augmentation
Eligibility:
FEMALE
21+ years
Phase:
PHASE4
Brief Summary
This study aims to learn more about the effects of aging and lip filler treatment on lips and the surrounding skin by comparing, among two different age groups of people, changes in the blood vessels ...
Detailed Description
This study will investigate aging of the cutaneous changes of human skin anatomy in the lips and perioral area to better understand and quantify the aging process in this, including the effect of age ...
Eligibility Criteria
Inclusion
- Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
- In good general health, based on answers provided during the screening visit;
- Subjects must be able to read and understand English;
- Caucasian female;
- Aged 21-30 years and post-menopausal;
- Skin Types (all Fitzpatrick Skin Phototypes );
- Smoking history is self-report.
- Have very thin to moderately thick lips (Lip Fullness Grading Scale \[LFGS\] scores 0-2).
Exclusion
- Participation in another investigational drug or device clinical trial in the past 30 days;
- Are pregnant or lactating;
- Intake of hormone replacement therapy (HRT) in the past 6 months;
- Have a history of drug or alcohol abuse or have reported habitual alcohol intake greater than 2 standard drinks per day \[e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks\];
- Presence of eczema, psoriasis, or any other skin disease on the lips or perioral skin;
- Have birth marks, tattoos, scars, or any other disfiguration of the skin in the skin area of interest;
- Use of any anti-aging skin care products containing retinoic acid, retinol, or other retinoids (e.g. tazarotene, adapalene) or estrogen on the skin area of interest in the past 6 months;
- Use of any prescription topical medication, such as corticosteroids or hydroquinone on the skin area of interest in the past 6 months;
- Have a history of photodynamic therapy treatment or any skin rejuvenation procedure on the skin area of interest;
- History of blood-clotting abnormality;
- History of keloid formation or hypertrophic scarring;
- Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study;
- Exhibits any clinical conditions or takes any medication which in the opinion of the investigator may interfere with the study or pose a risk to subject safety during the study;
- Is not able to follow study protocol;
- Have permanent lip implant, and lip enhancement or laser therapy performed within the preceding 12 months;
- Known history of allergy or sensitivity to glycerol, Tegaderm, lidocaine, hyaluronic acid dermal fillers or materials with gram-positive bacterial proteins.
Key Trial Info
Start Date :
May 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04839692
Start Date
May 7 2021
End Date
August 1 2022
Last Update
July 28 2023
Active Locations (1)
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1
MGH Clinical Unit for Research Trials & Outcomes Research
Boston, Massachusetts, United States, 02114